1. Field of the Invention
The present invention relates to medical applicator instruments and more particularly to vaccinating and testing needle assemblies.
2. Description of Related Art
Bifurcated or forked end needles are well-known for providing a simple and effective means for a doctor to administer a vaccine. During use, the bifurcated tip of the bifurcated needle is put into contact with either a dried or liquid substance which adheres to the bifurcated needle tip. The bifurcated needle tip is then put into contact with the skin of the patient who is being administered the vaccination. The skin is either scratched or pierced with the needle tip so that the vaccination material may be absorbed into the skin of the patient. An alternative method of delivering the vaccination includes placing a drop of the vaccine onto the skin of the patient and contacting the skin of the patient with the bifurcated needle tip through the drop of vaccine. Alternatively, a standard pointed needle tip may also be used when the drop of vaccine is applied directly to the skin of the patient.
The bifurcated needle is considered a significant medical advancement because it has allowed more people to be vaccinated with less serum. This has been especially important for those living in less developed areas because of the efficient and easy to use design, as well as the ease of replication.
Vaccination effectiveness, however, is reduced if the bifurcated needle is reused too many times. Moreover, reuse of such vaccination needles exposes patients to the risk of transmission of infectious diseases through percutaneous contact through the skin. Additionally, medical care workers using traditional vaccination needles are at an increased risk of exposure to infectious diseases due to the design of such needles, which makes them difficult to handle, as well as due to the repeated use of such needles.
In particular, bifurcated needles used to administer vaccinations are not traditionally sterilized or packaged in a single-use container that would enable convenient storage and subsequent use. Additionally, such needles have traditionally been difficult to handle in that they typically do not include a hub attached to the opposite end of a needle from the tip, and do not typically include any sort of shield for protection from the needle prior to and during use.
For example, U.S. Pat. No. 3,194,237 to Rubin discloses a vaccinating needle having a main shank with a pair of prongs at one end that define a slot of predetermined length, width and depth therebetween to hold an amount of liquid by capillary action. The shank of the needle is of sufficient length so that the non-prong end will function as a handle. U.S. Pat. No. 3,948,261 to Steiner discloses a reusable unit dose container for vaccines contained within a rigid receptacle, with a compressible closure for supporting a bifurcated needle bearing dried vaccine. The closure is adapted to support the needle in the container during a lyophilizing process while liquid vaccine is dried on the needle. The closure has grooves which permit the vaporized liquid from the vaccine to be withdrawn from the receptacle during lyophilizing, and can further seal the container.
Moreover, various needles have been disclosed including handle mechanisms, such as U.S. Pat. No. 3,119,391, which discloses a non-coring needle having a flange-like manipulating surface, and U.S. Pat. No. Des. 426,304, which discloses a vaccination needle with a flange-like handle. Such needles, however, do not provide effective structure for sterile packaging and for protection.
There exists a need for a safety assembly for use with a unit dose vaccination needle that is easily manufactured, that is simple to use, that is easily sterilized and maintained in a sterile condition until used, that can be safely disposed of, and that does not interfere with normal practices of bifurcated needle use.
The invention provides a sterile, single-use needle assembly for administering a unit dose of a vaccine, including a hub, a unit dose needle, and two packaging covers extending over the ends of the assembly to maintain sterility of the assembly. The unit dose needle includes an elongated body having a blunt handle end and a patient end configured to hold a unit dose of a vaccine. The hub includes a first end and a second end, and is fixedly attached to the elongated body of the unit dose needle between the patient end and the blunt handle end, with the patient end of the unit dose needle extending from the first end of the hub and the blunt handle end of the unit dose needle extending from the second end of the hub. A first packaging shield is removably attached to the first end of the hub, and a second packaging shield is removably attached to the second end of the hub, such as through a threaded engagement. The attachment between the first packaging shield and the hub forms an air-tight seal, with the unit dose needle contained within the first packaging shield in a sterile environment.
The unit dose needle may include a bifurcated needle, with the patient end including two pointed prongs which are capable of penetrating or abrading the skin of a patient. The prongs are desirably separated by a U-shaped channel capable of holding the unit dose of a vaccine, such as a liquid vaccine.
It is an advantage of the present invention that the rigid sleeve covers provide easy containment and sterility of the needle assembly prior to use. A notable advantage of the second rigid sleeve cover is that in certain embodiments it can remain connected to the second end of the hub to be used as a handle and assist the user in directing the use of the needle so as to easily and accurately administer a vaccination to a patient or to conduct testing on a patient.